LYNDA STJOUR
Director of Quality
Executive Summary & Candidate Overview
Demonstrated expertise in quality management spanning pharmaceuticals, biologics, drug manufacturing, clinical trials, and clinical laboratory oversight.
Known for her positive attitude and ability to inspire others, with a knack for managing complex problems with creative and articulate solutions.
Valuable contributor as an expert in regulatory trends and GxP/EMA guidance, providing assistance to executive teams and various departments.
Accomplishments and Key Performance Indicators (KPIs)
Led global quality initiatives for internal cell therapy drug manufacturing facilities, ensuring compliance with FDA/EU (EMA) GxP regulations.
Developed and improved the quality management system (QMS) for a new manufacturing facility, covering deviation management, CAPA, change control, audits, and documentation.
Provided strategic and tactical leadership for the design, construction, commissioning, and qualification of a new vector manufacturing facility in Illinois.
Played a pivotal role in the first technology transfer of hyperstacked lentiviral manufacturing and ensured compliance with clean room qualification and equipment validation.
Authored and reviewed SOPs, policies, and job descriptions, interpreting FDA and EMA regulations for compliance.
Managed a $1M budget and implemented quality agreements for manufacturing cell/gene therapy products for multiple biotechnology companies.
Location and Travel
Open to: On-Site, Hybrid, and Remote Roles.
Remote Roles: Willing to consider remote opportunities based on specific position requirements.
Compensation Seeking: Open to discussing compensation details upon scheduling a meeting.
Position Seeking: Seeking Director-level roles in Validation or Technical Operations within the pharmaceutical industry.
Work Experience
Director, Quality at Bristol Myers Squibb
Global quality leadership for internal cell therapy drug manufacturing facilities.
Quality Director, Cell Therapy at Moffitt Cancer Center
Leadership and strategic guidance for continuous compliance with FDA, FACT-JACIE, ISO, ICH, JCAHO, and CLIA regulations.
Director, Quality – Divisional at LabCorp
Oversight of 30 clinical laboratories in nine different states, ensuring adherence to CLIA guidelines and regulations.
Quality & Safety Manager – Regional at LabCorp
Continuous improvement initiatives for laboratories and patient service centers, preparation and hosting of external audits, and management of audit findings.
Medical Technologist at Westat
Medical technologist role with NHANES, ensuring compliance with CLIA guidelines and regulations.
Quality Assurance Coordinator at CryoCell International
Quality assurance role in a cord blood and research facility, overseeing cord blood stem cell batch record data and participating in facility accreditations.
Medical Technologist at DSI Laboratories
Medical technologist and phlebotomist role in a pediatric center, conducting laboratory assays and ensuring quality control and assurance procedures.
Education
Master of Science in Health Administration from Ohio Dominican University
Bachelor of Science in Clinical Laboratory Science from Florida Gulf Coast University
